Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

The FDA continues to work to restore medical manufacturing crippled by hurricane Maria in Puerto Rico, but none of the plants has reached 70 percent of its pre-storm capacity, FDA Commissioner Scott Gottlieb told a congressional committee.

Device manufacturers in Puerto Rico produce “many sophisticated and medically-necessary products,” such as pacemakers and blood-collection equipment, Gottlieb told the subcommittee on oversight and investigations of the House Energy and Commerce Committee Oct. 24.

A focus of the FDA’s efforts is maintaining electrical power for the factories, Gottlieb said. Most plants are running on generators, but many of the generators are old and cannot be counted on for sustained operation, and they all need fuel to operate.